AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A multiCenter phase I study of aUtologous CD19 CAR T cElls for therapy refractory chronic GvHD (CURE-cGvHD)

This study is investigating a new type of treatment for chronic Graft-versus-Host Disease (cGvHD). This condition can be a serious complication for some people after they've had a stem cell transplant. In cGvHD, the donated cells attack the patient's own body. The treatment being tested uses the patient's own immune cells, called T-cells, which are specially modified in a lab to fight the disease. This is a very early-stage trial, focusing on understanding if the treatment is safe and how it affects the body. Researchers want to find out if these specially designed cells can help people whose cGvHD hasn't improved with other treatments.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Universitaetsklinikum Erlangen AöR

Enrolment target

Start

27 Mar 2026

chronic Graft-versus-Host-Disease (cGvHD)

What is this study about?

This study is looking into a new and experimental treatment for a condition called chronic Graft-versus-Host Disease (often shortened to cGvHD). cGvHD can sometimes develop after a patient has had a stem cell transplant, which is often used to treat certain cancers or blood disorders. In cGvHD, the new, healthy cells from the donor (the 'graft') mistakenly start to attack the patient's own body (the 'host'), leading to a range of ongoing health problems.

The treatment being tested is a type of 'cell therapy' that uses a patient's own immune cells, called T-cells. These T-cells are taken from the patient's blood, specially changed in a lab, and then given back to the patient. The idea is to 're-programme' these T-cells to target and fight the cells that are causing cGvHD. This initial study will help doctors learn if this new treatment is safe and works in the body.

Because this is a very early study (called a Phase 1 trial), the main goal is to test the safety of this new treatment and to see what effects it has. The researchers hope that this new approach could eventually offer a new way to help people whose cGvHD hasn't gotten better with standard treatments.

Key takeaways

This study tests a new cell therapy for chronic GvHD.
It uses your own immune cells, specially modified.
The main aim is to assess safety and how it works.
It's for people with cGvHD that hasn't responded to other treatments.
Participants must be 18 or over.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have chronic Graft-versus-Host Disease (cGvHD) that has not responded well to other treatments you've tried. The research team will review your medical history very carefully to make sure the study might be right for you and that you meet all the specific requirements.

There might be other health conditions or treatments that would mean you couldn't take part, as this is an early-stage study focusing on safety. The study doctors will talk you through all of these details.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic Graft-versus-Host Disease (cGvHD)?
Has your cGvHD not improved with other treatments?
Are you willing to follow a detailed study plan and attend regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure the treatment is suitable for you. This would involve various tests and discussions with the study team. If you are eligible, some of your blood would be collected – similar to a normal blood donation – to gather your T-cells.

These cells would then be sent away to a special lab where they are modified before being given back to you through a drip. After receiving the treatment, you would have regular appointments, tests, and check-ups with the study team. These visits are important for the doctors to monitor your health, see how the treatment is affecting you, and manage any side effects. The total length of your involvement in the study, including follow-up visits, would be explained to you by the research team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment for your cGvHD that could help when other treatments haven't. However, because this is a new treatment, there are also potential risks, including side effects that are not yet fully known. The study team will explain all the known and potential risks in detail, and you'll be closely monitored throughout. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is chronic Graft-versus-Host Disease (cGvHD)?

It's a complication that can happen after a stem cell transplant where the new donated cells attack the patient's own body.

What are CAR T-cells?

These are your own immune cells that have been specially changed in a lab to better fight your disease.

Is this a new treatment?

Yes, this is a very new and experimental treatment, which is why it's being studied in an early-stage trial.

What is a Phase 1 study?

It's the first stage of human testing, mainly focused on checking if a new treatment is safe and how it works in the body.

Can I still have my regular treatment if I join?

The study team will discuss how this new treatment might fit with any existing treatments you are having.